drugset / Trial / NCT05213728
A Phase 1, Open-label, Safety and Immunogenicity Study of an Oral Multi-dose Administration Regimen With an Adenoviral-vector Based Tablet Norovirus Vaccine (VXA-G1.1-NN) Administered to Healthy Adult Volunteers
NaSingle-groupOpen-labelPrevention
Summary
Subjects will receive multiple sub-doses over a 4-hour period to deliver a total overall dose of 1E11. Evaluations of immunogenicity, safety, and tolerability will be evaluated. The active period consists of data collection at Day 1, Day 8, and Day 29. Safety follow-up continues by phone screen at Day 180 and Day 365.
Timeline
- Start
- 2022-01-24
- Primary completion
- 2022-02-01
- Completion
- 2022-02-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VXA-G1.1-NN | Vaccine | 1e+11 iu | Oral |